Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site

Neoplasms, Unknown Primary Clinical Trial

Official title:

A Randomized, Phase III Comparison of Gemcitabine/Irinotecan Followed by IRESSA Versus Paclitaxel/Carboplatin/Etoposide Followed by IRESSA in the First-Line Treatment of Patients With Carcinoma of Unknown Primary Site

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193596
• Other study ID #: SCRI UNKPRI 12
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: March 22, 2013
• Start date: September 2003
• Est. completion date: June 2009

Study information

• Verified date: March 2013
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.

Description:

Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms:

• Paclitaxel + Carboplatin + Etoposide

• Irinotecan + Gemcitabine

Patients will be stratified by tumor location (liver/bone versus all others) and number of metastatic sites (one versus two or more). Patients with an objective response or stable disease after completion of chemotherapy will receive ZD1839 until disease progression. Patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive ZD1839 if they have an objective response or stable disease. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

• Carcinoma of unknown primary site

• Biopsy-proven metastatic carcinoma

• Able to perform activities of daily living with minimal assistance

• No previous treatment with any systemic therapy

• Measurable or evaluable disease

• Adequate bone marrow, liver and kidney function

• Understand the nature of this study and give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

• Age < 18 years

• Uncontrolled brain metastases and meningeal involvement

• Other uncontrolled malignancies

• Women pregnant or lactating

• Recent history of significant cardiovascular disease

• Severe or uncontrolled systemic disease

• Other significant clinical disorder

• Clinically active interstitial lung disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Neoplasms, Unknown Primary

Intervention

Drug:
• Etoposide
50 mg alternating with 100 mg PO, days 1 and 10 in regimen A
• Gemcitabine
1000 mg/m2 IV, days 1 and 8, in regimen B
• Irinotecan
1000 mg/m2 IV days 1 and 8 in regimen B
• Paclitaxel
200 mg/m2 by 1-hour IV infusion, day 1, regimen A
• Carboplatin
Area under the curve (AUC) 6.0 IV, day 1, regimen A

Locations

Country	Name	City	State
United States	Cancer Outreach Associates	Abingdon	Virginia
United States	Phoebe Cancer Center	Albany	Georgia
United States	Northeast Alabama Regional Medical Center	Anniston	Alabama
United States	Tower Oncology	Beverly Hills	California
United States	Graves-Gilbert Clinic	Bowling Green	Kentucky
United States	Aultman Hospital	Canton	Ohio
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Consultants in Medical Oncology and Hematology	Drexel Hill	Pennsylvania
United States	Oncology Hematology Associates of SW Indiana	Evansville	Indiana
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan
United States	Terrebonne General Medical Center	Houma	Louisiana
United States	Clearview Cancer Institute	Huntsville	Alabama
United States	Jackson Oncology Associates	Jackson	Mississippi
United States	Northeast Arkansas Clinic	Jonesboro	Arkansas
United States	Kingsport Hematology-Oncology	Kingsport	Tennessee
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Watson Clinic Center for Cancer Care and Research	Lakeland	Florida
United States	Consultants in Blood Disorders and Cancer	Louisville	Kentucky
United States	Wellstar Cancer Research	Marietta	Georgia
United States	Mercy Hospital Miami	Miami	Florida
United States	Montana Cancer Institute Foundation	Missoula	Montana
United States	Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group	Mobile	Alabama
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Methodist Cancer Center	Omaha	Nebraska
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	St. Joseph Mercy Oakland Hospital, Cancer Center	Pontiac	Michigan
United States	Mercy Hospital	Portland	Maine
United States	South Texas Oncology and Hematology	San Antonio	Texas
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Reading Hospital Regional Cancer Center	West Reading	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	AstraZeneca, Eli Lilly and Company, Pharmacia and Upjohn

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hainsworth JD, Spigel DR, Clark BL, Shipley D, Thompson DS, Farley C, West-Osterfield K, Lane CM, Cescon T, Bury MJ, Greco FA. Paclitaxel/carboplatin/etoposide versus gemcitabine/irinotecan in the first-line treatment of patients with carcinoma of unknown — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death	Length of time, in months, that patients were alive from their first date of protocol treatment until death.	24 months	No
Secondary	Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease	Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease	12 months	No

External Links

•   Published article in The Cancer Journal